Electric wheelchair
by Freewheel Medical Co., Ltd 54 variants
Ref FW322, FW102-C, FW406, FW503, FW201-ER, FW201-F, FW604, FW202, FW405, FW903, FW103-S, FW006, FW001, FW312-04, FW502, FW308, FW312-02, FW104-S, FW801, FW706, FW602, FW902, FW101-S, FW802, FW202-F, FW004, FW606, FW003, FW316-02, FW603, FW702, FW316-03, FW316-ER, FW905, FW601, FW102-M, FW316, FW102-A, FW203, FW205Model FW001,FW002,FW003,FW004,FW005,FW006 FW101-C,FW101-M,FW101-A, FW101-S FW102-C,FW102-M,FW102-A, FW102-S FW103-C,FW103-M,FW103-A, FW103-S FW104-C,FW104-M,FW104-A, FW104-S,etc
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697825420FW01M6 | Date24 Jan 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Electric wheelchair
- Model / Reference
- FW001,FW002,FW003,FW004,FW005,FW006 FW101-C,FW101-M,FW101-A, FW101-S FW102-C,FW102-M,FW102-A, FW102-S FW103-C,FW103-M,FW103-A, FW103-S FW104-C,FW104-M,FW104-A, FW104-S, etc, FW322, FW102-C, FW406, FW503, FW201-ER, FW201-F, FW604, FW202, FW405, FW903, FW103-S, FW006, FW001, FW312-04, FW502, FW308, FW312-02, FW801, FW706, FW602, FW902, FW101-S, FW802, FW202-F, FW004, FW606, FW003, FW316-02, FW603, FW702, FW316-03, FW316-ER, FW905, FW601, FW102-M, FW316, FW102-A, FW203, FW205
- Primary DI / UDI-DI
- 06978254200535, 06978254200108, 06978254200627, 06978254200658, 06978254200252, 06978254200238, 06978254200726, 06978254200269, 06978254200610, 06978254200894, 06978254200177, 06978254200054, 06978254200009, 06978254200450, 06978254200641, 06978254200405, 06978254200429, 06978254200214, 06978254200818, 06978254200801, 06978254200702, 06978254200887, 06978254200092, 06978254200832, 06978254200276, 06978254200030, 06978254200740, 06978254200023, 06978254200504, 06978254200719, 06978254200764, 06978254200511, 06978254200498, 06978254200917, 06978254200696, 06978254200115, 06978254200467, 06978254200122, 06978254200306, 06978254200382
- Basic UDI-DI
- 697825420FW01M6
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000046098
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Freewheel Medical Co., Ltd
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No